Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Efficacy and safety of three doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer's disease

Acronym

Study hypothesis

To demonstrate efficacy of at least one dose of S 38093 as compared to placebo on primary endpoint

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

A 24-week international, multi-centre, randomised, double-blind, placebo-controlled phase IIb study followed by a 24-week extension period

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Mild to moderate Alzheimer's disease

Intervention

1. 2, 5 or 20mg/day of S 38093 or placebo, orally, during a 24-week treatment period + 24-week treatment extension period2. A 2-6-week selection period without study treatment will be followed by a 24-week double-blind treatment with 4-parallel groups (doses : 2, 5 and 20 mg/day of S38093 and placebo) and a 24-week optional treatment extension period (patients on placebo will be re-randomised to S 38093 2; 5 or 20mg) and a 2-week follow-up period3. One tablet of S 38093 (2, 5 or 20mg) or placebo will be taken orally, once a day, during study participation from inclusion visit +1 until follow-up period

Secondary outcome measures

Overall trial start date

22/08/2011

Overall trial end date

30/04/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 55-85 years 2. School education more than or equal to 4 years3. Able to perform neuropsychological tests4. Have adequate visual and auditory acuity with the usual corrective aids to allow neuropsychological testing 5. Have a responsible informant Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for Dementia of the Alzheimer's type 6. National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's disease (AD) 7. Mini-Mental State Examination (MMSE) between 15 and 24

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Inpatients 2. Female patients of child-bearing potential 3. Dementia due to any condition other than AD 4. History of epilepsy or solitary seizure 5. History or presence of Parkinson's disease or Parkinsonism 6. Major neurological or neurodegenerative conditions associated with significant cognitive impairment such as Multiple Sclerosis or Huntington's Disease 7. Major psychiatric conditions

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

IPD sharing statement:The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.